A Clinical Study of Hyperthyroidism in Children

NCT ID: NCT06570967

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-18

Study Completion Date

2027-12-31

Brief Summary

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This study intends to conduct a retrospective and prospective study on children with hyperthyroidism, and it is a non-intervention study to collect information on diagnosis and treatment and long-term follow-up of children with hyperthyroidism. To investigate the clinical characteristics, treatment effect, side effects and remission of hyperthyroidism in children, to analyze the predictive factors for the effect of antithyroid drug treatment, remission and recurrence after drug withdrawal, and to explore the risk factors related to the occurrence of antithyroid drug-related adverse reactions.

Detailed Description

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Conditions

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Hyperthyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Methimazole(MMI)

The initial dose of methimazole was 0.2-0.8 mg/(kg▪d). This dose was subsequently reduced by 25% to 50% and adjusted to maintain euthyroidism, based on the results of serum thyroid hormone testing during follow-up.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≤14 years old
2. Initial diagnosis of hyperthyroidism

Exclusion Criteria

1. Hyperthyroidism had been treated with medication in other hospitals,
2. History of autoimmune hepatitis, viral hepatitis, hematological diseases, bone marrow or liver transplantation,
3. Patients with incomplete clinical data
Minimum Eligible Age

29 Days

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shi Tang

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shi Tang, Doctor

Role: CONTACT

+8618940259064

Facility Contacts

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Ying Xin, Doctor

Role: primary

+8618940251876

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1223

Identifier Type: -

Identifier Source: org_study_id

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